UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025384 |
|---|---|
| Receipt number | R000029225 |
| Scientific Title | Examination of nutritional education on soft drink intake for children dwelling in a children's home |
| Date of disclosure of the study information | 2016/12/23 |
| Last modified on | 2017/12/29 05:32:55 |
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Basic information
Public title
Examination of nutritional education on soft drink intake for children dwelling in a children's home
Acronym
Examination of nutritional education on soft drink intake for children dwelling in a children's home
Scientific Title
Examination of nutritional education on soft drink intake for children dwelling in a children's home
Scientific Title:Acronym
Examination of nutritional education on soft drink intake for children dwelling in a children's home
Region
| Japan |
Condition
Condition
Child
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining of a healthy-food practice approach for soft drink intake
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amounts and Times of Soft drink intake 1week after nutrition education
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group nutrition education(2time) and change of food environment
Interventions/Control_2
Group nutrition education(1time) and change of food environment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 13 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Female
Key inclusion criteria
Junior and senior high school students
children dwelling in a children's home
Key exclusion criteria
not selected
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukari Takemi |
Organization
Kagawa nutrition university
Division name
Nutrition ecology
Zip code
Address
3-9-21 Chiyoda, Sakado, Saitama
TEL
049-282-3721
takemi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomi Takahashi |
Organization
Chiba Local Government Health and Welfare Department
Division name
Health Promotion Support Division
Zip code
Address
1-1 Ichiba-chou,chuo-ku, Chiba-city, Chiba
TEL
043-223-2667
Homepage URL
n.sn2@pref.chiba.lg.jp
Sponsor or person
Institute
Kagawa nutrition university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 23 | Day |
Last modified on
| 2017 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029225
